During an audit, the best way to determine whether an audited process is consistent with the requirements of the relevant written procedure is by

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Physically observing the actual practice is the best way to determine whether an audited process is consistent with the requirements of the relevant written procedure. This way, the auditor can see if the personnel are following the steps outlined in the procedure and identify any deviations or non-conformances. Statistical analysis of historical data or evaluating anecdotal evidence may provide some information, but they do not provide a direct observation of the current process. Questioning personnel who perform the procedure may provide some insight, but it is subject to bias and may not be reliable without actual observation.

During an Audit, the Best Way to Determine Whether an Audited